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Phase 3 Randomized Study of ALKS 2680 for Excessive Daytime Sleepiness in Adults with Narcolepsy Type 1

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What is this trial about?

A plain-language summary of the goals, design and what participants do

A clinical investigation is being conducted in adults diagnosed with Narcolepsy Type 1, a rare neurological condition characterized by overwhelming daytime drowsiness and sudden episodes of muscle weakness called cataplexy. The study evaluates the oral tablet form of ALKS 2680 and compares it with an inactive substance known as placebo to determine whether the medication can reduce the persistent feeling of excessive daytime sleepiness, which is the tendency to fall asleep unintentionally during daily activities.

The main aim of the trial is to assess whether the drug improves daytime alertness in participants with this condition. Volunteers will be randomly assigned to receive either the active medication or the inactive comparator, and they will take the assigned tablet each day for approximately twelve weeks. Throughout the study period, participants will attend regular visits where simple questionnaires and brief safety checks will be performed to monitor how they feel and to ensure the treatment is well tolerated.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and randomization

    After joining the study, a baseline visit is scheduled. during this visit, measurements of daytime sleepiness and cataplexy are recorded, and questionnaires such as the epworth sleepiness scale are completed.

    Based on the baseline data, you are randomly assigned to receive either alks 2680 tablets or a matching placebo tablet.

  2. Step 2

    Start of medication

    On the day following randomization, you begin taking the assigned tablet.

    The tablet is taken oral (by mouth) and is formulated as a tablet.

    The specified dose is 00 mg per tablet.

    The medication is taken daily for a period of up to 12 weeks, unless instructed otherwise by the study team.

  3. Step 3

    Regular monitoring visits

    Throughout the 12‑week treatment period, you attend scheduled clinic visits.

    At each visit, safety checks are performed, side effects are reviewed, and you may complete additional questionnaires.

    Objective tests such as the maintenance of wakefulness test may be administered to assess alertness.

  4. Step 4

    Week 12 assessment

    At the end of week 12, a comprehensive assessment is conducted.

    The primary outcome measured is the change in the epworth sleepiness scale score from baseline.

    Secondary outcomes include the change in mean sleep latency on the maintenance of wakefulness test, the weekly cataplexy rate, and other patient‑reported outcomes.

  5. Step 5

    End of treatment and final evaluation

    After the week 12 assessment, the study medication is discontinued.

    A final evaluation is performed to record any remaining effects and to ensure safety.

    Study data are then compiled for analysis.

Who can join the trial?

7 criteria

  • Be between 18 and 70 years old when you sign the study consent.
  • Be willing and able to sign a document that explains the study, called informed consent, before you start.
  • Have a body mass index (a measure of weight compared to height) of at least 18 and no more than 40 kg/m² at the first visit.
  • Your doctor believes you are not getting enough benefit or are having side effects from current narcolepsy medicines (unsatisfactory clinical response), and you can safely stop those medicines for the study, following the required washout periods (time for the medicines to leave your body).
  • Be able to follow the study rules, including lifestyle limits and using birth‑control methods if needed (contraception guidance).
  • Be able to use and keep the required sleep monitoring tools: a wrist device that tracks movement (actigraphy), a diary to record sudden muscle weakness episodes (cataplexy diary), and a diary to record your sleep patterns (sleep diary).
  • If you are treated for blocked breathing during sleep (obstructive sleep apnea), you must have used that treatment regularly for at least 30 days before the first visit and continue using it throughout the study (adherence to therapy).

Who cannot join the trial?

14 criteria

  • Has uncontrolled and serious sleep‑breathing problems, such as a high number of breathing pauses during sleep (apnea‑hypopnea index ≥ 15 per hour), or if using a breathing device still has an average of ≥ 10 pauses per hour, or has frequent central breathing pauses (central apnea index > 5 per hour).
  • Shows abnormal results on laboratory tests taken at the first visit, as described in the study plan.
  • Is currently taking, or has taken in the past 6 months, antidepressant medicines for any reason other than controlling cataplexy (sudden loss of muscle tone).
  • Is pregnant, breastfeeding, or plans to become pregnant during the study.
  • Is already part of another experimental treatment study, or has used any investigational drug or device within 30 days before the first visit, including previous participation in Study ALKS 2680‑201.
  • Works for Alkermes, the contract research organization (CRO), the study site, or is an immediate family member (spouse, parent, sibling, or child) of such an employee.
  • Has another sleep disorder or condition that could affect the normal sleep‑wake cycle, as listed in the study plan.
  • Has a serious heart or blood‑vessel disease during screening or within the past 2 years, as detailed in the study plan.
  • Has a major mental health disorder or substance‑use problem, defined according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), as described in the study plan.
  • Has a significant other illness, disease, abnormality, or past surgery that the investigator believes could jeopardize safety, interfere with study measurements, or prevent completion of the study. This includes major brain disorders such as dementia, neurodegenerative diseases, stroke, or seizures (except isolated childhood fever seizures).
  • Has a current or recent (within 6 months) gastrointestinal disease that could affect how medicines are absorbed, such as a history of malabsorption or any stomach surgery, including a Roux‑en‑Y gastric bypass or similar procedures.
  • Has a history of cancer (treated or untreated) in the past 5 years, except for resolved carcinoma in situ or basal cell skin cancer, which may be allowed with special approval.
  • Has a known risk for, or a history of, narrow‑angle glaucoma (eye condition where the drainage angle is too small).
  • Has a positive alcohol breath test or a urine drug screen showing drugs of abuse at the fourth visit.
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Investigated drugs

ALKS 2680 is an experimental oral tablet being tested as a possible treatment for excessive daytime sleepiness in adults who have narcolepsy type 1. In the study, participants take this tablet to see if it can help them stay awake and feel more alert during the day. The trial compares the effects of ALKS 2680 with a placebo to determine how well the medication works and how safe it is for people with this sleep disorder.

What is already known about the treatment

ALKS 2680 - ALKS 2680 is taken as an oral tablet that patients swallow with water. It is an experimental drug that is still being studied and has not yet received approval, so it appears only in early clinical research and trial reports. The medicine is being tested to help people with narcolepsy type 1 who feel excessively sleepy during the day. It works by activating the brain’s orexin (wake‑promoting) system, and it is classified as an orexin‑2‑receptor agonist.

Investigated diseases

Narcolepsy type 1 - Narcolepsy type 1 is a neurological condition that causes overwhelming daytime sleepiness. People with this condition often fall asleep suddenly, even during normal activities. It is also linked with episodes of sudden muscle weakness triggered by strong emotions, known as cataplexy. Over time, the frequency of sleep attacks and cataplexy episodes may increase, affecting daily routines.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523911-13-00Protocol codeALKS 2680-302Estimated enrolment178 patientsSponsorAlkermes Inc.

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